NCT04254146

Brief Summary

Background: RA may progress with articular and non-articular involvement.Depression prevelance is found to increase for RA patients according to healthy population and to be correlated with pain, decreased quality of life, fatigue and physical disability.BDNF level was found significantly lower in RA patients with depression. Aim of this study is to investigate the variation of BDNF levels following acute exercise and potential correlation between BDNF levels and depression. Methods: This study included 30 RA patients and 30 age and sex matched healthy controls.Depression levels were evaluated with Beck Depression Inventory (BDI) and Hospital Anxiety and Depression Scale (HADS). Blood samples from all subjects were taken and centrifuged before and immediately after the exercise intervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

January 31, 2020

Last Update Submit

June 17, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisBrain Derived Neurotrophic Factoracute exercise

Outcome Measures

Primary Outcomes (1)

  • BDNF levels

    Blood samples from all subjects will be taken and centrifuged before and immediately after the exercise intervention. Obtained serums will be stored at the laboratories of Firat University.

    1 minute

Secondary Outcomes (2)

  • Beck Depression Inventory

    2 minutes

  • Hospital Anxiety and Depression Scale

    2 minutes

Study Arms (2)

Study group

EXPERIMENTAL

Aerobic exercise will be performed for a single session

Other: Aerobic exercise

Control group

ACTIVE COMPARATOR

Aerobic exercise will be performed to healthy population for a single session

Other: Aerobic exercise

Interventions

Aerobic exerciseOTHER

Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise.

Control groupStudy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were aged between 18-65 years,
  • Patients who got diagnosed according to American College of Rheumatology criteria
  • Patients who were being followed at Firat University Department of Rheumatology

You may not qualify if:

  • Patients who had regular exercise habits, malignancy, pregnancy, incorporation,
  • Patients who took anti-TNF treatment
  • Patients who had changes of medical treatment in last 3 months
  • Patients who diagnosed with Fibromyalgia Syndrome and Osteoarthritis for lower extremity
  • Patients who had cardiac symptoms according to New York Heart Association
  • Patients who had dysfunction that can prevent physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Gülnihal Deniz

Elâzığ, 23000, Turkey (Türkiye)

RECRUITING

Songul Baglan Yentur

Elâzığ, 23000, Turkey (Türkiye)

RECRUITING

Süleyman Serdar Koca

Elâzığ, 23000, Turkey (Türkiye)

RECRUITING

Zübeyde Ercan

Elâzığ, 23000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Grimsholm O, Rantapaa-Dahlqvist S, Dalen T, Forsgren S. BDNF in RA: downregulated in plasma following anti-TNF treatment but no correlation with inflammatory parameters. Clin Rheumatol. 2008 Oct;27(10):1289-97. doi: 10.1007/s10067-008-0910-4. Epub 2008 May 17.

    PMID: 18484150BACKGROUND

  • Szuhany KL, Bugatti M, Otto MW. A meta-analytic review of the effects of exercise on brain-derived neurotrophic factor. J Psychiatr Res. 2015 Jan;60:56-64. doi: 10.1016/j.jpsychires.2014.10.003. Epub 2014 Oct 12.

    PMID: 25455510BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Süleyman S Koca

    Firat University

    STUDY DIRECTOR

Central Study Contacts

Songul B Yentur

CONTACT

0424 237 8282songulbaglan23@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

January 31, 2020

Primary Completion

October 2, 2020

Study Completion

December 2, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(4)